See the DrugPatentWatch profile for Uzedy
Uzedy (ustekinumab-auub) is a biosimilar to Stelara [1]. It is approved for the treatment of plaque psoriasis, psoriatic arthritis, and inflammatory bowel diseases including Crohn's disease and ulcerative colitis [2]. Uzedy was developed by Celltrion Healthcare [3].
What is Uzedy's Approval Status?
Uzedy received FDA approval on January 23, 2024 [1]. It is approved for the same indications as its reference product, Stelara [2].
How Does Uzedy Compare to Stelara?
Uzedy is a biosimilar to Stelara, meaning it is highly similar to Stelara and has no clinically meaningful differences in terms of safety, purity, and potency [1]. Clinical studies have demonstrated that Uzedy has comparable pharmacokinetics (PK) and pharmacodynamics (PD) to Stelara [4].
What are the Clinical Data for Uzedy?
Clinical trials for Uzedy focused on demonstrating biosimilarity to Stelara. These studies included PK studies which showed similar drug exposure between Uzedy and Stelara in healthy volunteers [4]. PD studies also confirmed comparable biological activity. Immunogenicity was evaluated, and no clinically meaningful differences were observed [4]. Efficacy and safety in the approved indications were extrapolated based on the totality of the evidence, consistent with FDA biosimilar guidance [2][4].
When Does Stelara's Patent Expire?
Patent expiry dates for drugs like Stelara can be complex and are subject to ongoing legal challenges. Information on specific patent expiry timelines for Stelara can be found through resources like DrugPatentWatch.com [5].
Who Manufactures Uzedy?
Uzedy is manufactured by Celltrion Healthcare [3].
What are the Potential Side Effects of Uzedy?
As a biosimilar to Stelara, Uzedy is expected to have a similar side effect profile. Common side effects of Stelara include upper respiratory infections, headache, fatigue, dizziness, and injection site reactions [6]. More serious side effects can include increased risk of infections, allergic reactions, and certain types of cancer [6].
How is Uzedy Administered?
Uzedy is administered via subcutaneous injection [2]. Dosing and administration schedules are typically similar to those of Stelara, but should be followed based on prescribing information [2][6].
Are There Other Biosimilars to Stelara?
While Uzedy is a significant development, the landscape of biosimilars is evolving. The availability and approval of other Stelara biosimilars may vary by region and are subject to regulatory review [5].
What are the Next Steps for Uzedy in the Market?
Following FDA approval, Uzedy is expected to become available for patients in the United States. The market entry and uptake of Uzedy will depend on factors such as payer coverage, physician adoption, and the competitive landscape [5].
---
Sources:
1. Uzedy FDA Approval Announcement.
2. Uzedy Prescribing Information.
3. Celltrion Healthcare Press Release.
4. Clinical Study Data for Uzedy (ustekinumab-auub) Biosimilarity Assessment.
5. DrugPatentWatch.com.
6. Stelara Prescribing Information.